Opportunities & Challenges in Latin America

Guidelines on Tapping the Potential That Exists in This Emerging Market

Mexico

Mexico is the leading pharmaceutical market in Latin America. The Mexican market, as an initial entry point into the region, can serve as an important foothold for companies looking to enter the rest of Latin America. However, certain characteristics of the environment in Mexico need to be taken into account.

As in Brazil, changes in the Health Ministry happen often. Moreover, currently, a number of regulations are under review which could mean more regulatory changes are on the horizon. By 2012, 40 blockbuster drugs will come off patent, further signaling big changes in the Mexican pharmaceutical market.

As the leading pharmaceutical market in Latin America, Mexico experienced over 200% growth in foreign direct investment (FDI) from 1999 to 2006, with $346 million FDI in 2006 alone. The Mexican pharmaceutical market has been growing at a rate of 12% per year.

Most of the major pharmaceutical companies have a presence in the Mexican market. In fact, the pharmaceutical industry in Mexico is considered one of the most well developed in Latin America. It represented 1% of Mexico’s GDP, and 37% of Latin American pharmaceutical sales in 2006 were attributable to Mexico.

While Mexico represents the largest pharmaceutical market, there is relatively less clinical research being undertaken there. However, the growing number of clinical trials being conducted in Mexico is an encouraging indication of the country’s potential in this area.

The regulatory body responsible for clinical trials in Mexico is the Comision Federal para la Proteccion Contra Riesgos Sanitarios (COFEPRIS). The total approval and set-up process in Mexico can take anywhere between 13 and 17 weeks. Because the process is sequential, additional sites must be approved by COFEPRIS, which takes four weeks. Additionally, an insurance certificate endorsed by a local insurance company is required before a site can be activated.

The key initial documents required for clinical trials in Mexico are the protocol, ICF, and IB. Ethics committees must approve the protocol per site; only once the first site’s EC approval and the site’s director authorization letter are ready can the protocol be submitted to COFEPRIS for clinical trial authorization. If a site has a scientific committee in addition to an ethics committee, approval by both is necessary.

In addition to a relatively quick approval process, Mexico also has a reputation as a cost-effective site for clinical trials. A U.S. Department of Commerce report suggested that sponsors might be able to save as much as 30% in costs related to a clinical trial in Mexico, as compared to conducting it in the U.S.

Moreover, a growing population in Mexico and a high occurrence of major diseases, particularly cancer and heart disease, indicated that Mexico is poised to see an increase in clinical trials. In 2008, there were 683 clinical trial sites in the country.

Of particular importance to companies interested in conducting clinical trials in Mexico is a 1986 regulation, the Reglamento de la Ley General de Salud en Materia de Investigacion para la Salud. This regulation controls all aspects of scientific and technological research related to healthcare.

For a pharmaceutical company entering the Mexican market, different options are available for registering new products depending on whether it is an imported product as opposed to local manufacturing. A company can file the dossier with a filing or an approval letter in the reference country.

It is worth noting that only an abbreviated dossier is necessary in Mexico; it consists mostly of CMC data, summaries, and some clinical reports. However, a CFS/certificate of a pharmaceutical product is mandatory for approval.

One positive recent development in Mexico has been the removal of the requirement for import licenses for drugs or for export licenses on blood serum samples. The introduction of this update has essentially reduced the start-up timeline from what was 3.5–4.5 months to 3–4 months. This is effectively bringing the Mexican regulation more in line with some European countries.

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